Obesity or Overweight
Conditions
Interventions
Experimental: Arm 1: AZD9550 low dose + AZD6234 low dose or placebos
Drug: AZD9550
- IMP injected subcutaneous, once weekly. Unit dose strength as per CSP
Drug: AZD6234
- IMP injected subcutaneous,
Sponsors
Ageishi Yuji
Eligibility
Inclusion criteria
Inclusion criteria: - Participant must be 18 to 75 years of age inclusive. - BMI: or more 30 kg/m2, or or more 27 kg/m2 with at least one weight related comorbidity. - A stable, self-reported body weight for 3 months prior to screening. - Male and female participants: Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. - Capable of giving signed informed consent.
Exclusion criteria
Exclusion criteria: - History of any clinically important disease or disorder, which, in the opinion of the Investigator, may put the participant at risk. - History or presence of GI, renal, hepatic disease. - Previous or planned bariatric surgery or fitting of a weight loss device. - Obesity induced by endocrine disorders such as Cushing's syndrome, insulinoma or Prader-Willi syndrome. - History of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucose control. - HbA1c or more 6.5% (48 mmol/mol), fasting serum glucose or more 126 mg/dL (7.0 mmol/L) or random glucose or more 200 mg/dL (11.1 mmol/L). - Significant gastric and hepatobiliary disease. - History of acute or chronic pancreatitis or pancreatic amylase or lipase > 2 x ULN at screening. - History of psychosis or bipolar disorder. - History of major depressive disorder within the 2 years prior to screening or depression. - Treatment with a GLP1 containing preparation, either as part of treatment or while participating in another clinical study within the 3 months or 5 half-lives of the drug prior to screening. - Vulnerable populations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percent change in body weight from baseline after 36 weeks of treatment To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss [Time Frame: 36 weeks] - Weight loss or more 5% from baseline after 36 weeks of treatment To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo on the proportion of participants with weight loss or more 5%. [Time Frame: 36 weeks] | — |
Countries
Australia, Canada, Germany, Japan, Taiwan, United Kingdom, United States of America
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed